Davita Union City Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of one of one Licensed Practical Nurse (LPN AA), and two of two Patient Care Technicians (PCTs BB and CC) observed and interviewed, to correctly verify the hemodialysis (HD) machine’s dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s Directions For Use (DFU) and facility’s procedure. This deficient practice had the potential to cause harm to 16 of 16 patients ( P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17 and P#18), who were undergoing hemodialysis treatment at the time of this observation. The facility census was 61. Findings include: Cross Reference: V 250 - Failure of the facility to follow the manufacturer’s DFU in verifying the machine’s dialysate pH and conductivity prior to the initiation of HD treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observations, facility record review, staff interviews, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedure (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 61 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Cross References: V 250 - Failure of the facility to accurately perform independent testing of the machine’s dialysate’s (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity) and conductivity (ability of the dialysate to conduct electricity)according to the Manufacturer’s DFU and facility’s P & P prior to the initiation of each patient treatment and when the dialysate’s formulation was changed. V 726 - Failure of the facility to ensure that the Registered Nurse/Charge Nurse provided accurate information when patient (P#1), was first admitted to this facility.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 33921 Based on observation, staff interview, a review of facility Policy and Procedures (P& P), and Centers for Disease Control and Prevention (CDC) Recommendations, it was determined that the Infection Control Committee failed to ensure that one of one Patient Care Technician (PCT BB) observed, performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes and after touching contaminated equipment. Failure to perform infection control techniques such as hand hygiene, increased the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect 16 of 16 patients (P), (P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17 and P#18), who were undergoing hemodialysis treatment at the time of this observation and eight of eight Direct Patient Care Staff (Registered Nurses (RN/CN, RN BB, Licensed Practical Nurse, LPN AA, Patient Care Technicians (PCTs AA, BB, CC and PCT Trainees, DD and EE), who were present during this observation. The facility in-center census was 61. Findings include: During observation in the Patient Treatment Room on 5/24/24 between 10:10 a.m. and 12:05 p.m., the following was revealed: - PCT BB was observed initiating patient, (P), P#10’s hemodialysis treatment at Station (S) 18. PCT BB picked up used gauze from the floor (dirty), then touched the hemodialysis machine (dirty). PCT BB then removed her contaminated gloves, and without performing hand hygiene, she went to get supplies from the supply drawer (clean). - PCT BB (who was also assigned to take care of P#9 in the Isolation Room and who was training PCT DD), was made aware of this observation on 5/24/24 at approximately 11:00 a.m., and she made no comment. - A review of the facility’s Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023 stated: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene: b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ...”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews, and review of facility records, it was determined that the Infection Control Committee failed to ensure that five of five Direct Patient Care Staff (Registered Nurse/Charge Nurse (RN/CN), Registered Nurse (RN BB), Patient Care Technicians (PCTs AA and BB), and PCT Trainee, PCT DD) observed, practiced infection control and prevention techniques to prevent cross contamination. This deficient practice had the potential to negatively affect the health and safety of 16 of 16 patients ( P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17 and P#18), who were undergoing hemodialysis treatment at the time of this observation. The facility in-center census was 61. Findings include: During observation in the Patient Treatment Room on 5/24/24 between 10:10 a.m. and 12:05 p.m., the following was revealed: - RN/CN, RN BB, PCTs AA and BB, when leaving the Patient Treatment Room (dirty area), to go to the Supply Room (clean area) to obtain clean supplies, failed to remove or change their gowns and Faceshields before entering the Supply Room. - Patient (P#9), who was positive for Hepatitis B surface Antigen (HBsAg), was undergoing hemodialysis treatment in the Isolation Room (Station 20). PCT BB did not remove the gown (white) she was using in the treatment room (general population) before entering the Isolation Room to care for P#9. Instead, PCT BB wore her isolation gown (yellow) on top of her regular gown (white), and did not fasten the waist and neck area of the isolation gown. When PCT BB bent over the side of P#9’s chair, the sides of the isolation gown slid towards the chair and floor exposing the white gown that was underneath PCT BB’s isolation gown. This deficient practice had the potential for cross contamination. PCT BB removed her isolation gown and went out of the Isolation Room to the Treatment Room wearing the same contaminated white gown. - PCT DD (a PCT Trainee who was being trained by PCT BB), repeated the same breach in Infection Control Technique by not removing the white gown used in the Treatment Room before entering the Isolation Room. PCT DD wore the isolation gown on top of the white gown and did not fasten the neck and waist parts of the isolation gown. When PCT DD was removing P#9’s fistula needles at the end of P#9’s treatment, PCT DD’s isolation gown slid off his shoulders and sides completely exposing the white gown underneath, and the hem of the isolation gown touched the floor. After removing the isolation gown, PCT DD went back to the Treatment Room with the same white gown. PCT DD repeated the same breach in infection control technique while disinfecting the hemodialysis chair in the Isolation Room after P#9 vacated the room. When PCT BB was notified of this observation on 5/24/24 at approximately 10:25 a.m., PCT BB did not make a comment. When PCT DD was notified of this observation on 5/24/24 at 11:00 a.m. PCT DD stated, “okay”. - A review of facility Policy: 1-05-01 titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023 stated: PPE (i.e. gown, gloves, eye protection, face shield) ... a. Removed prior to leaving the treatment area. b. PPE is not to be worn in non-treatment areas... - A review of Policy: 1-05-02, titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, with latest revision date of April 2024, stated: 17. PPE (Personal Protective Equipment) ... b. The long sleeved gown will be tied in the back and gloves will be pulled over the cuffs of the sleeves. c. PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of one of one Licensed Practical Nurse (LPN AA), and two of two Patient Care Technicians (PCTs BB and CC) observed and interviewed, to correctly verify the hemodialysis (HD) machine’s dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s Directions For Use (DFU) and facility’s procedure. This deficient practice had the potential to negatively affect the health and safety of 16 of 16 patients ( P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17 and P#18), who were undergoing hemodialysis treatment at the time of this observation. The facility census was 61. Findings include: During observation in the Patient Treatment Room on 5/24/24 between 10:10 a.m. and 12:05 p.m., the following was revealed: - LPN AA was observed testing the dialysate’s conductivity from Station (S) 10. LPN AA poured the dialysate sample into the Myron L D-1 meter cell cup, then she agitated the sample with the plunger by moving the plunger up and down three times. Then without discarding the sample, LPN AA pressed the black button and when the pointer stopped, she immediately read the conductivity and released the button. When asked at 10:22 a.m. on 5/24/24, how many times she was supposed to rinse and agitate the sample before testing, LPN AA stated that she just pour the sample into the cell and agitate it three times then check the result. When asked how many times she was supposed to check the conductivity result, LPN AA stated that because the “Myrons” were calibrated first thing in the morning, she only had to check the conductivity reading once. - PCT CC was asked if the dialysate’s pH and conductivity at S8 was tested. PCT CC stated that PCT EE, (who was being trained by PCT CC), had already tested the dialysate’s pH and conductivity. When PCT CC was asked how to test the dialysate’s pH, PCT CC stated on 5/24/24 at 11:25 a.m., that after collecting the dialysate sample, she would take the sample to the clean station, dip the pH strip for 30 seconds then immediately compare the strip to the color chart. - PCT BB was observed changing the patient’s dialysate at S18 from a standard bath (2 potassium /2.5 calcium formulation) to a jug with a 3.0 potassium /2.5 calcium formulation. PCT BB did not re-test the dialysate’s pH and conductivity after changing the dialysate formulation. PCT BB stated on 5/24/24 at 11:12 a.m. that she had tested the pH and conductivity earlier before changing the bath but did not re-test the dialysate’s pH and conductivity after changing the dialysate formulation. - At 11:15 a.m., PCT BB was observed performing the re-testing of the dialysate’s pH from S18 with the new formulation. PCT BB did not look at the clock and was swishing the pH test strip (RPC E-Z Chek K100-0117 - 6.8 - 8.5 Test Strip) for 10 seconds (surveyor’s time). Then PCT BB immediately compared the test strip to the color chart. The manufacturer’s DFU on the pH Test Strip Bottle stated, to dip the test strip into the dialysate sample for one second, shake off excess liquid and compare the strip to the color chart after 10 seconds. - A review of facility Procedure: 1-21-02 titled, “Operation of Portable Myron L Conductivity Meter (D-1)” with latest revision date of April 2020 stated: 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. RATIONALE: If electrode is not immersed, results may be affected. Verify the plunger is completely seated in the cell cup. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #4 - at least 3 times. RATIONALE: Verifies that any prior sample solution has been rinsed free from the cell. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press. Read/Check button and record conductivity reading. RATIONALE: Helps assure accurate reading. - A review of the facility’s Policy: 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” with latest revision date of April 2020 stated: 6. Independent pH is required to be performed prior to each treatment. 9. If using a non-central acid delivery system, follow manufacturer’s guidance to verify dialysate conductivity and pH when changing or replacing the acid container during the course of a treatment.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 33921 Based on observations, staff interview, a review of facility Policies and Procedures (P&P) and a review of Centers for Disease Control and Prevention (CDC) guidelines, it was determined that the Medical Director failed to ensure that all Direct Patient Care Staff (Nurses and Patient Care Technicians) observed, adhered to facility P&P related to infection control and prevention; and accurately perform independent testing of pH (acidity) and conductivity (ability to conduct electricity) of dialysate. This deficient practice had the potential to negatively affect the health and safety of 16 of 16 patients, (P), (P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17 and P#18), who were undergoing hemodialysis at the time of this observation. The facility census was 61. Findings include: Cross References: V113 - Failure of the Medical Director to ensure Patient Care Technician (PCT BB) performed hand hygiene after removing contaminated gloves and before obtaining clean supplies from the supply drawer. V115 - Failure of the Medical Director to ensure Direct Patient Care Staff (Nurses and Patient Care Technicians) follow facility Policy and Procedures relative to properly putting on and taking off Personal Protective Equipment to avoid cross contamination. V 250 - Failure of the Medical Director to ensure that one of one Licensed Practical Nurse (LPN AA) and two of two Patient Care Technicians (PCT BB and PCT CC) observed and interviewed, followed the Manufacturer’s DFU and the facility P&P regarding testing the machines’ dialysate pH (acidity) and conductivity (ability of the dialysate to conduct electricity) using RPC E-Z Chek K100-0117 6.8 - 8.5 pH strips and Myron L Conductivity Meter (D-1).”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 33921 Based on staff interviews and a review of facility records, it was determined that the facility failed to ensure that one of one Registered Nurse/Charge Nurse (RN/CN), who was responsible for admitting patient (P#1) to the facility, and in obtaining patient’s records prior to start of initial treatment and during this complaint investigation, presented an accurate information of P#1’s first day of treatment, who was later found to be Hepatitis B surface Antigen (HBsAg) positive. This deficient practice had the potential to negatively affect the health and safety of P#6 and P#7, who were seated in the same section with P#1, and who were susceptible to the Hepatitis B Virus (HBV) and Patient Care Technician (PCT AA), who was assigned to P#1, and who was also susceptible to the HBV. Findings include: - According to RN/CN on 5/24/24 at approximately 1:30 p.m., P#1 was admitted to this facility on 4/24/24 (Wednesday), and although the initial lab orders were created for 4/24/24, the Patient Care Technician (PCT AA), who was assigned to P#1, did not draw the labs. RN/CN further stated that P#1 came on 4/26/24 for treatment but his access was clotted so he did not dialyze. P#1 came back on 4/29/24, and his admission labs were drawn which resulted on 5/1/24, that showed that P#1 was HBsAg positive. RN/CN also added that when P#1 was admitted to this facility on 4/24/24, they had not received his records nor Hepatitis B Virus status. RN/CN stated that the facility knew he was coming but they didn’t know his actual start date, so when P#1 showed up at this facility on 4/24/24, after all the second shift patients had started dialyzing, RN CN stated that she placed a telephone call to the Medical Director (MD) on 4/24/24 (before initiating P#1’s dialysis treatment), and was told by the MD via phone call, to go ahead and initiate P#1’s treatment and to use the standard dialysis treatment orders. RN/CN added that since P#1’s Hepatitis B Virus status was unknown, P#1 was treated as a suspect patient for Hepatitis B infection and was assigned a seat at Station 4, the only available chair, according to RN/CN. - According to P#1’s treatment flowsheets provided, P#1 had undergone hemodialysis treatment at this facility on the following dates: - On 4/24/24, P#1 was seated at Station (S) 10 and on 4/29/24, P#1 was at S4 (both times with the general patient population). On 5/1/24, 5/3/24, and 5/8/24, (which was P#1’s last treatment at this facility), P#1 underwent hemodialysis treatment at S20 (Isolation Room). - RN/CN stated on 5/24/24 at 2:40 p.m., that P#1 had requested a transfer to a sister facility and was discharged from this facility on 5/10/24, but P#1 did not show up at the sister facility and was currently admitted at a hospital. - During a telephonic interview with the Medical Director on 5/24/24 at 3:52 p.m., MD stated that the facility was supposed to draw labs on the first day of admission, except if the first day of patient treatment was on a Saturday. MD also stated that P#1 was referred to her and she didn’t know that P#1 had positive HBsAg. - A review of facility Policy: 1-05-02 titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, with latest revision date of April 2024, stated: 1. HBV serological status (i.e., the results of Hepatitis B surface Antigen (HBsAg), Total Hepatitis B Core Antibody (total anti-HBc or HBcAb), and Hepatitis B Surface Antibody (anti-HBs or HBsAb) of all patients should be known before admission to the hemodialysis facility. 2. If the Hepatitis B surface Antigen (HBsAg) status is unknown, the facility Medical Director will be notified and the patient treated as a suspect patient for Hepatitis B infection... NOTE: DIALYZING CONFIRMED POSITIVE OR SUSPECTED/UNKNOWN STATUS Status: Unknown Antigen - Location: Station removed from the mainstream of activity Duration: Brief (i.e., less than week) Labs must be obtained ASAP (as soon as possible) (sic). - A review of P#1’s records (which according to RN/CN on 5/24/24 at approximately 2:30 p.m.), also showed that P#1 had a Hepatitis B lab results, dated 3/25/24 but did not show the name of the lab. The results showed: Hepatitis B surface Antigen, reactive; Hepatitis B Core AB, reactive; Hepatitis B surface Antibody, reactive... Data is abnormal! - When RN/CN was asked by this surveyor on 5/24/24 at approximately 2:40 p.m., about this result that was dated 3/25/24, she stated that this was part of the records that P#1 had but was not available when P#1 came to the facility on 4/24/24. - A review of P#1’s treatment flowsheets dated 4/24/24, showed, “Pre-treatment Fluid Calculation... Previous Post Treatment Weight 78.1 kg (dated 4/3/24)... When RN/CN was asked about this information, specifically previous treatment dated 4/3/24, RN/CN did not make a comment but shrugged her shoulders. When this surveyor asked if P#1 was treated at a sister facility on 4/3/24 (using the same CWOW - “Center Without Walls”, a cloud-based patient data platform used by the company, again RN/CN didn’t answer but shrugged her shoulders. - A review of the facility’s Risk Event Management (REM) report, (or Adverse Occurrence Report), showed that P#1 was admitted to this facility and had undergone hemodialysis treatment at this facility for the first time on 4/3/24, 4/24/24, and 4/29/24 and was treated in the general patient population. However, the admission documentation that the facility provided during the investigation survey, stated that P#1’s first treatment at the facility was on 4/24/24. - A telephonic interview with the RN/CN was conducted on 6/10/24 at 4:04 p.m., to verify P#1’s admission information, specifically, that P#1 was admitted on 4/24/24 (that was given during the investigation survey on 5/24/24). RN/CN stated that the dates “were mixed up”, that P#1 had actual first time hemodialysis treatment at the facility on 4/3/24, but was in the hospital between 4/5/24 to 4/22/24.”